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ISO 13485 QMS 

Documentation systems 
Executive and staff ISO training
Consulting
Internal and supplier ISO audits
Process optimization

ISO 13485 Quality Management Systems

• Manufacturing medical devices?
• Plan to sell products in Europe or Canada?
• Need to comply with FDA QSR's?
• Want to improve field action and customer complaint processes?
• Wish you could do things right the first time?

We can help! Quality Works assisted dozens of companies worldwide to establish and implement effective ISO 13485:2003 Quality Management Systems compliant with the FDA QSR’s. ISO 13485 is quality management system standard designed specifically for medical device manufacturers. The standard is mandatory for a number of classes of medical devices in Europe and Canada. The ISO 13485:2003 standard is based on ISO 9001:2000 standard, and has many of the same requirements. However, there are additional requirements for process control, design control, retention of records, traceability, compliance with regulatory requirements and more.

Check our products to see how our documentation sets can help you in developing your  Quality Management System or call us for a free, no obligation consultation. We can help!